NCT03622164

Unilateral Neck Radiotherapy in Head and Neck Cancer

Randomized Trial of Unilateral vs. Bilateral Neck Irradiation in Head and Neck Cancer Patients Treated With Primary Surgery

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with head and neck cancer typically undergo a surgical procedure to remove the lymph nodes that could contain disease on both sides of the neck. After surgery, radiotherapy is given (with or without chemotherapy) to the area that underwent surgery and both sides of the neck, even if disease was only found on one side. Giving radiotherapy to both sides of the neck commonly results in high rates of side effects, which in turn affects patient quality of life. There is growing evidence from some other studies that support the safety of omitting radiotherapy after surgery in the side of the neck with no disease. With this study, the investigators are hoping to justify its routine use and, if successful, the standard of care could be to receive radiation on only one side of the neck instead of both sides. This could alleviate the extent of some side effects and improve patient quality of life. Participants will be randomized into one of the following groups to receive radiotherapy as follows: Arm 1 (Non-experimental intervention): standard intervention: Radiotherapy to both sides of the neck. Treatment will begin a maximum of 8 weeks from the surgery date. Arm 2 (Experimental intervention): Radiotherapy to one side of the neck. Treatment will begin a maximum of 8 weeks from the surgery date.

Conditions

• Head and Neck Neoplasms

Interventions

Type	Name	Description
RADIATION	Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck)	CTV54 includes only the ipsilateral neck, including levels 2-4 plus levels 1 and/or 5 as clinically indicated.
RADIATION	Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck)	CTV54 includes the entire surgical bed, including bilateral neck lymphatics at risk of harboring microscopic disease

Timeline

• Start date: 2018-12-21
• Primary completion: 2025-02-27
• Completion: 2025-02-27
• First posted: 2018-08-09
• Last updated: 2025-06-27

Locations

1 site across 1 country: Canada